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An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Primary Purpose

Triple Negative Breast Cancer, Metastatic Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gedatolisib
PTK7-ADC
Sponsored by
Kathy Miller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Metastatic Triple-negative Breast Cancer
  • Willingness to undergo tumor biopsy
  • Patients must have received at least 1 prior chemotherapy regimen for metastatic disease

Exclusion Criteria:

  • Previous treatment with mTOR inhibitor
  • Untreated brain metastases

Sites / Locations

  • IU Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gedatolisb + PTK7-ADC

Arm Description

Outcomes

Primary Outcome Measures

Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported

Secondary Outcome Measures

Efficacy in all enrolled subjects
efficacy as determined by clinical benefit at 18 weeks
Overall response rate in all enrolled subjects
efficacy as determined by overall response rate
Progression free survival in all enrolled subjects
efficacy as determined by progression free survival
Pharmacodynamic determination of inhibition of PI3k signaling
Pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage inhibition between samples.
Pharmacodynamic determination modulation of Wnt pathway
pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage change in expression between samples.
Pharmacodynamic determination modulation of Wnt pathway
RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment

Full Information

First Posted
August 3, 2017
Last Updated
January 5, 2021
Sponsor
Kathy Miller
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1. Study Identification

Unique Protocol Identification Number
NCT03243331
Brief Title
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
Official Title
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
May 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathy Miller

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer, Metastatic Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Study will enroll 3 patients to the cohort 1 dose level. If 0 of 3 patients experience a DLT, the study will proceed to cohort 2. If 1 patient experiences a DLT, 3 additional patients will be enrolled into cohort 1. If 1 of 6 patients experience a DLT, the study will proceed and 3 patients will be enrolled to the cohort 2 dose level. If 0 patients experience a DLT in cohort 2, the study will proceed to cohort 3. If 1 patient experiences a DLT at cohort 2, 3 additional patients will be enrolled into cohort 2. If the study proceeds to cohort 3, 3 patients will be enrolled at this dose level. If 0 patients experience a DLT, the study will enroll an additional 3 patients at the cohort 3 dose level to better define the safety profile. If 1 of 3 patients experiences a DLT at cohort 3, 3 additional patients will still be enrolled into cohort 3. If 1 of 6 patients experience a DLT, the study will complete.
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gedatolisb + PTK7-ADC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gedatolisib
Intervention Description
Gedatolisb will be intravenously administered on Day 1, Day 8 and Day 15 of every 21 day cycle at a dose of 110 mg or 180mg depending on cohort assignment.
Intervention Type
Drug
Intervention Name(s)
PTK7-ADC
Other Intervention Name(s)
PF-06647020
Intervention Description
PTK7-ADC will be administered on Day 1 of every 21 day cycle at a dose of 1.4mg/kg or 2.8 mg/kg depending on cohort assignment.
Primary Outcome Measure Information:
Title
Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
Description
safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported
Time Frame
through study completion i.e. up to 1 year
Secondary Outcome Measure Information:
Title
Efficacy in all enrolled subjects
Description
efficacy as determined by clinical benefit at 18 weeks
Time Frame
18 weeks
Title
Overall response rate in all enrolled subjects
Description
efficacy as determined by overall response rate
Time Frame
through study completion i.e. up to 1 year
Title
Progression free survival in all enrolled subjects
Description
efficacy as determined by progression free survival
Time Frame
through study completion i.e. up to 1 year
Title
Pharmacodynamic determination of inhibition of PI3k signaling
Description
Pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage inhibition between samples.
Time Frame
Cycle 1 Day 15
Title
Pharmacodynamic determination modulation of Wnt pathway
Description
pathological H-score will be determined from tissue obtained at screening and Cycle 1 Day 15. H-score will be compared to calculate percentage change in expression between samples.
Time Frame
Cycle 1 Day 15
Title
Pharmacodynamic determination modulation of Wnt pathway
Description
RNA sequencing of tissue collected at screening and Cycle 1 Day 1 to compare Wnt pathway expression after treatment
Time Frame
Cycle 1 Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic Triple-negative Breast Cancer Willingness to undergo tumor biopsy Patients must have received at least 1 prior chemotherapy regimen for metastatic disease Exclusion Criteria: Previous treatment with mTOR inhibitor Untreated brain metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Miller, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milan Radovich, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

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